小儿腺样体扁桃体切除术后的阿片类镇痛:一项随机临床试验

Opioid Analgesia Following Pediatric Adenotonsillectomy: A Randomized Clinical Trial.

作者信息

Whelan Rachel L, McCoy Jennifer L, Mirson Leonid, Maguire Raymond C, Jabbour Noel, Simons Jeffrey P, Dohar Joseph E, Kitsko Dennis J, Stapleton Amanda L, Tobey Allison B J, Alper Cuneyt M, Shaffer Amber D, Bennett Zachary R, Chi David H

机构信息

UPMC Children's Hospital of Pittsburgh, Division of Pediatric Otolaryngology, Pittsburgh, Pennsylvania, USA.

University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.

出版信息

Otolaryngol Head Neck Surg. 2025 Aug;173(2):392-401. doi: 10.1002/ohn.1280. Epub 2025 May 21.

Abstract

OBJECTIVE

To compare the safety and efficacy of nonopioid versus opioid pain management following adenotonsillectomy (AT) among pediatric patients.

STUDY DESIGN

An open-label randomized controlled trial.

SETTING

Tertiary care children's hospital.

METHODS

Patients aged 3 to 17 years undergoing AT were eligible. Participants were randomly assigned to receive either acetaminophen and ibuprofen (nonopioid group) or acetaminophen, ibuprofen, and oxycodone (opioid group). Pain scores and prevalence of emergency department (ED) visits, hospital readmission, and posttonsillectomy hemorrhage (PTH) were compared between groups.

RESULTS

From January 2019 to March 2020, 267 patients were enrolled and randomly assigned; 144 completed a postoperative pain diary. Of the 144, 69 (48%) patients received an opioid prescription, and 75 (52%) did not. Mean pain scores before (opioid: 5.78, 95% CI: 5.29-6.27 vs nonopioid: 5.66, 95% CI: 5.20-6.12) and after (opioid: 2.33, 95% CI: 1.89-2.78 vs nonopioid: 2.24, 95% CI: 1.82-2.66) analgesics were not significantly different between opioid and nonopioid groups. Although 7/75 (9%) from the nonopioid group crossed over and requested opioids, only 43/69 (62%) randomly assigned to receive opioid prescription consumed opioids. The rate of opioid consumption increased with increasing age: 18/71 (25%) patients aged 3 to 7 years, 22/57 (39%) 8 to 12 years, and 10/16 (63%) 13 to 17 years, P = .015. Differences in ED visits, hospital readmissions, and PTH between opioid and nonopioid groups were not significant.

CONCLUSION

Many children do not require opioid analgesics following AT, particularly children less than 8 years of age. Postoperative pain scores and outcomes were similar in opioid versus nonopioid groups. Opioid prescriptions should be limited or avoided altogether after pediatric AT.

TRIAL REGISTRATION

Title: Nonopioids for analgesia after adenotonsillectomy in children; ID: NCT03618823, Clinicaltrials.gov.

摘要

目的

比较小儿腺样体扁桃体切除术(AT)后非阿片类与阿片类药物疼痛管理的安全性和有效性。

研究设计

开放标签随机对照试验。

研究地点

三级医疗儿童医院。

方法

年龄在3至17岁接受AT手术的患者符合条件。参与者被随机分配接受对乙酰氨基酚和布洛芬(非阿片类组)或对乙酰氨基酚、布洛芬和羟考酮(阿片类组)。比较两组之间的疼痛评分以及急诊科就诊、住院再入院和扁桃体切除术后出血(PTH)的发生率。

结果

2019年1月至2020年3月,共纳入267例患者并随机分配;144例完成了术后疼痛日记。在这144例患者中,69例(48%)接受了阿片类药物处方,75例(52%)未接受。阿片类组与非阿片类组在使用镇痛药之前(阿片类组:5.78,95%可信区间:5.29 - 6.27;非阿片类组:5.66,95%可信区间:5.20 - 6.12)和之后(阿片类组:2.33,95%可信区间:1.89 - 2.78;非阿片类组:2.24,95%可信区间:1.82 - 2.66)的平均疼痛评分无显著差异。虽然非阿片类组中有7/75(9%)的患者转而要求使用阿片类药物,但随机分配接受阿片类药物处方的患者中只有43/69(62%)实际使用了阿片类药物。阿片类药物的使用比例随年龄增长而增加:3至7岁的患者中有18/71(25%),8至12岁的患者中有22/57(39%),13至17岁的患者中有10/16(63%),P = 0.015。阿片类组与非阿片类组在急诊科就诊、住院再入院和PTH方面的差异不显著。

结论

许多儿童在AT术后不需要阿片类镇痛药,尤其是8岁以下的儿童。阿片类组与非阿片类组的术后疼痛评分和结果相似。小儿AT术后应限制或完全避免使用阿片类药物处方。

试验注册

标题:儿童腺样体扁桃体切除术后非阿片类药物镇痛;编号:NCT03618823,Clinicaltrials.gov。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/210e/12312295/4e4d4430f8ce/OHN-173-392-g002.jpg

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